NCT05275049

Neuromodulation in MS Using Translingual Stimulation

Translingual Stimulation Combined With Physiotherapy to Improve Walking and Balance in Multiple Sclerosis: an RCT

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The overarching aim of this study is to examine if there is additional benefit to adding trans-lingual electrical stimulation to physiotherapy aimed at improving walking and balance in people with multiple sclerosis (MS).

Detailed description

This is a two arm, participant-blinded, interventionist blinded, and research assessor-blinded RCT Participants with walking problems due to MS (Patient Determined Disease Steps PDDS 3-6) will be randomized 1:1 after baseline assessment stratified into 2 arms (lower walking disabilities PDDS 3+4, and higher walking disabilities PDDS 5+6) Following a 14 week balance and walking training intervention, participants will be instructed to continue to exercise independently according to the evidence-based Physical Activity Guidelines in MS for a subsequent 12 weeks. They will be reassessed at the end of that time (FOLLOW-UP).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PT plus translingual stimulation device	PoNS device will be used to deliver trans-lingual electrical stimulation. The stimulation will be delivered while the participants engages in evidence-based physiotherapy for walking and balance.
COMBINATION_PRODUCT	PT plus translingual stimulation control device	Control device will be used. Participants will wear device while engaging in evidence-based physiotherapy for walking and balance.

Timeline

• Start date: 2021-07-05
• Primary completion: 2022-07-05
• Completion: 2022-12-01
• First posted: 2022-03-11
• Last updated: 2022-03-11

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated device study